Application 022150

Type: NDA
Sponsor: SHIRE ORPHAN THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FIRAZYR	ICATIBANT ACETATE	INJECTABLE;SUBCUTANEOUS	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022150-001	FIRAZYR	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022150-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2011-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022150-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022150-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022150-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022150-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022150-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022150-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022150-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022150-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022150-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022150-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022150-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022150-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022150-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022150-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022150-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022150-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022150-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022150-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022150-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022150-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022150-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022150-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022150-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022150-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022150-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022150-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022150-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022150-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022150-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022150-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022150-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022150-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022150-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022150-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022150-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022150-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022150-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022150-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022150-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022150-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022150-001	5648333	2019-07-15	U-1187	Drug substance, Drug product	2011-09-22	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022150-001	5648333	2019-07-15	U-1187	Drug substance, Drug product	2011-09-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022150-001	5648333	2019-07-15	U-1187	Drug substance, Drug product	2011-09-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022150-001	5648333	2019-07-15	U-1187	Drug substance, Drug product	2011-09-22	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Firazyr	ICATIBANT ACETATE	Takeda Pharmaceuticals America, Inc.	ed6657ca-ab68-477a-9968-e12dc928b540	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022150 application number: NDA022150 ndc (product): 54092-702

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-135	Icatibant	Icatibant	Takeda Pharmaceuticals America, Inc.	NDA AUTHORIZED GENERIC	Current
54092-135	Icatibant	Icatibant	Takeda Pharmaceuticals America, Inc.	NDA AUTHORIZED GENERIC	Current
54092-135	Firazyr	icatibant acetate	Shire US Manufacturing Inc.	NDA AUTHORIZED GENERIC	Current
54092-702	Firazyr	icatibant acetate	Shire US Manufacturing Inc.	NDA	Current
54092-702	Firazyr	icatibant acetate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-702	Firazyr	icatibant acetate	Shire US Manufacturing Inc.	NDA	Current
54092-702	Firazyr	icatibant acetate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-702	Firazyr	icatibant acetate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-702	Firazyr	icatibant acetate	Shire US Manufacturing Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77278	SUPPL	2024-01-23
77266	SUPPL	2024-01-23
70916	SUPPL	2022-05-03
70882	SUPPL	2022-05-02
62588	SUPPL	2020-04-17
62587	SUPPL	2020-04-17
62586	SUPPL	2020-04-17
62585	SUPPL	2020-04-17
17018	SUPPL	2015-11-25
6966	SUPPL	2015-11-25
17017	SUPPL	2015-08-11
6965	SUPPL	2015-08-11
17016	SUPPL	2013-09-09
29323	SUPPL	2013-09-04
42431	ORIG	2011-10-03
29322	ORIG	2011-08-29
17015	ORIG	2011-08-26